510(k) K014157 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
| Applicant | Philips Medical Systems, Seattle WA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jan 17, 2002 |
| Received | Dec 19, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K014157
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG on screen; configurable manual charge in advance mode. Terminated |
MKJ | None listed |
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) model:
M3840: LAERDAL brand; configurable ECG on screen; configurable manual charge in advance mode. Terminated |
MKJ | None listed |
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) model:
M3861: PHILIPS brand; text prompts only on screen (NO ECG); no configurable manual charge. Terminated |
MKJ | None listed |
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge. Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.